Senior Specialist, Product Performance, Medical Affairs

Abbott • Temecula, CA

9d • $99,300 - $198,700 • Hybrid

About The Position

The Sr. Specialist Clinical Product Performance will work within the Abbott Vascular division, focusing on innovative, minimally invasive, and cost-effective products for vascular disease treatment. This role is for a specialist professional individual contributor with comprehensive knowledge in medical or clinical interventional therapies. The position provides daily business operations support to cross-functional teams as part of the Clinical Product Performance function and has the ability to execute highly complex or specialized projects. The role assists in developing a strategy for the division's medical oversight product performance function.

Requirements

• Bachelors Degree in Pharmacy, Nursing, RT, Life Science, or other health-related field, or equivalent qualification
• 5+ years of relevant experience
• Experience working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience.

Nice To Haves

• A background in cardiology, cardiac surgery or vascular medicine/surgery is preferred.
• Highly prefer MD, RN or RT with Cath Lab experience
• Strong ability to work cross functionally, understand various needs across diverse functions, and prioritize work according to business unit needs.
• Experience prioritizing and managing project initiatives across multiple functions and/or business units.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business model
• Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment -- multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong project management, team skills, and influential management
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Adept at handling multiple assignments in a timely manner and meeting assigned deadlines

Responsibilities

• Daily responsibility/scope for on-market product and clinical study product performance, including post-market clinical data from commercial use of products.
• Overseeing the direction, planning, execution, clinical trials/research and product quality/safety activities.
• Providing oversight for on-market product and product performance functions, including monitoring of product safety related items (i.e. complaints, MDRs), reporting, evaluation, and safety in post-market and clinical trials.
• Reviewing and evaluating product performance data and trends to provide early identification of issues related to product performance or usage concerns in order to minimize clinical safety risk.
• Designing changes to product performance assessment and management to improve ongoing monitoring and risk assessment.
• Analyzing customer complaints and coordinating with PPG to determine which are regulatory reportable and acting as a key contact for activities with internal, field, and end use customers.
• Coordinating and providing reporting information for reports submitted to the regulatory agencies as applicable.
• Reviewing complaint communications and assessing for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Investigating complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Serving as a key resource in areas of MDR reporting, post-market product experience, and risk management.
• Understanding compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.
• Recognizing and reporting adverse events and product complaints according to established regulations, DOP's and guidelines.
• Compiling medical and scientific information for Abbott products and products in development and ensuring that clinical information is of high quality and communicated in an accurate, balanced, timely and compliant way.
• Maintaining thorough knowledge of assigned devices, drugs, history, and disease states treated to provide scientifically balanced medical devices and drug information to inquiries on Abbott Vascular products and associated disease states from multiple sources, including telephones, letters, faxes, business reply cards and e-mail from internal and external customers.
• Working cross functionally with division Compliance, Clinical Science, Regulatory Affairs, Medical Affairs and Commercial organizations, as required.
• Involvement with all on-market product performance, product performance, quality compliance, clinical science, medical information, scientific, and regulatory groups within Abbott.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior